Kornimate/medical-research-clean huggingface dataset:
genetic predictors of raltegravir penetration into cerebrospinal fluid

Conditions: HIV Infections

Summary: this study is being done to find out how much of the drug raltegravir (rgv) gets into cerebrospinal fluid (csf), compared to how much get into the blood and to find out if normal changes in a certain gene in your body affects how much rgv gets into the csf.

the multidrug efflux transporter p-glycoprotein (p-gp) is expressed in the blood-brain barrier where it limits entry of substrate drugs into the central nervous system. raltegravir (mk-0158), a new hiv-1 integrase inhibitor and potentially major addition to the therapeutic armamentarium against hiv, is a substrate for p-gp. studies are warranted to elucidate the relevance of p-gp transport for raltegravir in the central nervous system.

Eligibility criteria:
inclusion criteria: 1. able to give informed consent. 2. negative hiv-1 serology. 3. at least 18 but no more than 55 years of age. 4. body mass index \<30. 5. estimated creatinine clearance ≥ 50 ml/minute within 30 days prior to study entry. 6. within 30 days prior to study entry: * absolute neutrophil count ≥ 1,000/mm3. * hemoglobin ≥ 12.5 g/dl for males and ≥ 11.5 g/dl for females. * platelet count ≥ 100,000/mm3. * ast, alt, and total bilirubin within normal range. * alkaline phosphatase \< or = 1.5 x upper limit of normal. 7. female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 30 days before study entry. 8. must agree not to participate in a conception process. 9. drug transporter gene abcb1 position 3435 genotype c/c or t/t. exclusion criteria: 1. use of any medication that is metabolized by cyp3a or ugt1a1. 2. anticipated need to take any medication that is metabolized by cyp3a or ugt1a1 during the study. 3. active drug use or dependence. 4. inability to abstain from alcohol-containing beverages, grapefruit, and grapefruit juice. 5. serious illness that would interfere with study participation. 6. hospitalization for any reason or therapy for serious illness within 14 days prior to study entry. 7. history of hypersensitivity to study drug or its formulation. 8. as determined by the investigator, a significant active or previous history of cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). this is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that may affect drug absorption, etc. 9. breast-feeding. 10. evidence of cns infection or space occupying lesion by history or physical examination. 11. history of significant cns disorder. 12. prisoners or subjects who are compulsorily detained. 13. abcb1 position 3435 c/t heterozygosity.

Keywords: raltegravir csf abcb1 snp hiv/aids
examining interactions between pals and caregivers

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (als) and their caregivers. the question is, what are the effects of communicative interaction on verbal communication in people with als when they interact with their caregivers and does this change over time? participants will read words and sentences while they are interacting with their caregivers.

pals and caregivers will participate in two sets (pre-test and post-test) of interactive tasks two weeks apart. over two weeks, they will complete the collaborative word-matching task ten times (once every weekday for an average of 10 mins/day) on their own. the study is designed to examine two things. first, to examine the speech produced by pals with familiar interlocutors. second, to examine the changes in speech production as a function of collaborative practice. plans for assignment - this is a single group study in which all participants will engage in the same tasks. delivery of intervention: using tablets and audio recording devices provided to them, participants will complete this task in the comfort of their home. study protocols will be explained via videoconferencing by experimenters. produced speech will be recorded using solid-state audio recorders as well as remotely through the video conferencing software. adequacy of sample size. assuming medium effect sizes (cohen's f = 0.3) based on our pilot data, for 80% power at an alpha of .05, the investigators will require 76 speakers. the investigators propose n =76 pals and their caregivers (total 152) in order to account for speech variability that is common for pals. adequacy of analyses. the proposed statistical analyses (generalized mixed effects regressions) are standard and will be used to analyze the effect of the intervention on the outcome measures described below. severity of condition (for pals) will be included in the analyses and by-subject slopes and intercepts will be used to account for variability across participants.

Eligibility criteria:
inclusion criteria: speakers with amyotrophic lateral sclerosis (als) (pals-people with als) * diagnosis of als following the revised el escorial criteria * no history of other neurological conditions (e.g., stroke) * no cognitive impairment assessed by telephone montreal cognitive assessment (mini moca) * detectable speech disturbance according to the als functional rating scale-revised (alsfrs-r) * the ability to produce single words * being a native speaker of american english (ae). caregivers * being a caregiver of a participant with als * being a native speaker of american english (ae). exclusion criteria: - none - if volunteer meets the inclusion criteria, then they will be enrolled
effects of dexmedetomidine during ire procedures for solid tumours

Conditions: Cancer of Liver; Cancer of Pancreas

Summary: the purpose of the study is to evaluate effects of dexmedetomidine on anaesthesia during ire procedures for solid tumours

pulsed electric current can be used to produce irreversible electroporation (ire) of cell membranes with resulting cell death. this process has been shown to ablate tumors in animal and human studies. a pulsating direct current of 20 to 50 a and 500 to 3000 v is delivered into metastatic or primary tumors in the liver, kidney, or lung via needle electrodes inserted under computed tomography (ct) or ultrasound guidance. patients usually require general anesthesia with muscle relaxant. currently, circa 30 procedures have been done at our institution with good or excellent results. however, several patients have had severe pain postoperatively. dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. we will evaluate perioperative dexmedetomidine 0.4 µg/kg/hr infusion effects on hemodynamics, anesthetic consumption, and recovery profiles during anesthesia for ire of solid organs tumours.

Eligibility criteria:
inclusion criteria: 1. liver or/and pancreas cancer for which ire procedure is planned 2. signed informed consent form exclusion criteria: 1. patient refusal 2. pregnancy 3. known allergy to dexmedetomidine or other anaesthesia drugs 4. atrioventricular block grade ii or iii or other significant cardiac conduction disturbance 5. stroke 6. low blood pressure not responding to treatment
integrin alpha-v-beta and [18f]-r01-mg-f2 pet/ct in measuring response in patients with pancreatic cancer and healthy volunteers

Conditions: Healthy Subject; Pancreatic Carcinoma

Summary: this pilot clinical trial studies the use of integrin alpha-v-beta \[18f\]-r01-mg-f2 positron emission tomography/computed tomography (pet/ct) and positron emission tomography-magnetic resonance imaging in (pet/mri) in measuring response in patients with pancreatic cancer and healthy volunteers. integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers. \[18f\]-r01-mg-f2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.

primary objectives: i. evaluate the biodistribution and safety of \[18f\]fp-r01-mg-f2 in healthy volunteers. ii. evaluate the feasibility of \[18f\]fp-r01-mg-f2 pet/ct scanning in patients with pancreatic cancer. outline: patients receive \[18f\]fp-r01-mg-f2 intravenously (iv) and undergo pet/ct or pet/mr scan immediately after and at 60 and 120 minutes. patients will be followed up at 24-48 hours.

Eligibility criteria:
inclusion criteria: healthy volunteers: 1. must be 18 years of age or older. 2. must have no known medical problems and have had a full medical exam within 6 months of the study. if healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures. 3. must understand and voluntarily have signed an informed consent after its contents have been fully explained. 4. women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose. pancreatic cancer subjects: 1. participant must be 18 years or older at the time of radiotracer administration 2. provides written informed consent 3. suspected or established diagnosis of pancreatic cancer based on any radiographic scan or pathology and who is scheduled for surgery or biopsy proven diagnosis of pancreatic cancer who is no longer a surgical candidate exclusion criteria: healthy volunteers: 1. participant is less than 18 year-old 2. pregnant or breast feeding women. 3. patients who are not likely to comply with the protocol requirements. pancreatic cancer subjects: 1. participant is pregnant or breast-feeding 2. participant is not able to comply with the study procedures 3. participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements 4. metallic implants (contraindicated for mri) 5. history of renal insufficiency (only for mri contrast administration)
the effect of naproxen on the pharmacokinetic profile of lc350189 in healthy adults

Conditions: Gout; Hyperuricemia

Summary: this is a phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of lc350189 and naproxen when administered alone and in combination in healthy subjects.


Eligibility criteria:
inclusion criteria: * the subject is male or female 18 to 50 years of age, inclusive. * the subject has a body mass index 18 to 32 kg/m2, inclusive, at screening. * the subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ecg) results, and physical examination findings at screening. * the subject agrees to comply with all protocol requirements. * the subject is able to provide written informed consent. exclusion criteria: * the subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator. * the subject has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening. * the subject has an estimated glomerular filtration rate (egfr) of \<90 (ml/min)/1.73 m2. * the subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol \[up to 2 g per day\]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study. * the subject has consumed grapefruit or grapefruit juice, seville orange or seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study. * the subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug. * the subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake \>21 units per week for male subjects and \>14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint \[200 ml\] of beer, 1 small glass \[100 ml\] of wine, or 1 measure \[25 ml\] of spirits). * the subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
a clinical study for assessment of the efficacy and safety of mirtazapine (smilon) in depression patients with pain

Conditions: Depression; Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of smilon® in the depression patients with pain. eligible patients will be randomly assigned to 1 of 2 arms, either smilon® or placebo, and will receive the treatment for 8 weeks in this study.


Eligibility criteria:
inclusion criteria: * male or female * age 20-65 years * diagnosis of at least one chronic pain syndrome and the diagnosis of concomitant depression according to dsm-iv criteria * have a mean weekly pain score of at least 30 mm on the 100-mm visual analog scale (vas) of the short-form mcgill pain questionnaire (sf-mpq) before study entry exclusion criteria: * women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives * known hypersensitivity to mirtazapine or any of its components * subjects who have a clinically significant or unstable medical or psychiatric condition * subjects who have received nerve blocks or acupuncture for pain relief

Keywords: mirtazapine smilon depression pain
long-term effects of blueberry supplementation on brain health in older adults

Conditions: Cognitive Decline; Nutrition, Healthy; Brain Injuries

Summary: this study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.

in a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.

Eligibility criteria:
inclusion criteria: * adults aged 65-99 years * able to travel to brigham and women's hospital for 4 clinic visits exclusion criteria: * known allergies to blueberries * unable to abstain from blueberry consumption during the study period * inability to provide informed consent * planned major surgery during study period or recent major surgery up to 3 months before recruitment * organ transplant * plan to move out of greater boston area during the study period * diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.
phase 3 study of bi 207127 in combination with faldaprevir and ribavirin for treatment of patients with hepatitis c infection, including patients who are not eligible to receive peginterferon: hcverso2

Conditions: Hepatitis C, Chronic

Summary: the aim of the study is to confirm efficacy and safety of treatment with 600 mg of bid bi 207127 in combination with 120 mg qd fdv and rbv for 16 or 24 weeks in target chronically infected hcv gt1b treatment naïve patients, including patients with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: 1. chronic hepatitis c infection, diagnosed by positive anti-hcv antibodies and detected hcv rna at screening 2. hcv infection of sub-gt1b confirmed by genotypic testing at screening. 3. hcv viral load =1,000 iu/ml at randomisation. 4. patients who have never been previously treated with any other hcv treatment regimen. exclusion criteria: 1. hcv infection of mixed gt (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2. hcv infection of sub-gt1a, mixed gt1a/1b, or undefined gt1. 3. liver disease due to causes other than chronic hcv infection. 4. hiv infection. 5. hepatitis b virus infection based on presence of hbs-ag. 6. confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening. 7. history of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation. 8. subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis). 9. decompensated liver disease, or history of decompensated liver disease. 10. clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia. 11. red blood cell disorders. 12. body weight \ 125 kg.
effect of isometric handgrip training on ambulatory blood pressure in patients with hypertension

Conditions: Hypertension

Summary: meta-analysis studies have demonstrated that isometric training with handgrip promotes reductions in clinical blood pressure, reaching 8 mmhg for systolic blood pressure and 4 mmhg for diastolic. however, the effects of this training modality on ambulatory blood pressure, which is better discriminant of cardiovascular risk than clinical bp, remains uncertain. thus, the isopress network, consists of researchers from brazilian institutions of education and research (federal university of santa catarina, federal university of amazonas, federal university of sergipe, federal rural university of pernambuco and universidade nove de julho), will conduct a multi-center study to analyze the effects of isometric handgrip training on clinic and 24-h ambulatory blood pressure in patients with hypertension. for this, each research center will conduct a randomized controlled trial with medicated patients with hypertension, of both sex. the participants will be randomized into two groups: isometric handgrip training group (hbt: n = 25 per center) and control group (cg: n = 25 per center).subjects assigned to the hbt will train three times per week, four sets of 2-min isometric contractions (using alternate hands) at 30% of maximal voluntary contraction, during 24 weeks. subjects randomized to the cg will perform stretching and relaxation exercises three times per week, during 24 weeks. the evaluations will occur in three moments: baseline, post-12 and post-24 weeks. the primary outcome will be ambulatory blood pressure, while clinic blood pressure and cardiac autonomic modulation will be analyzed as secondary outcomes. for data analysis, in addition to descriptive statistics, two-way anova for mixed model will be applied for within and between groups comparison. the level of significance that will be adopted is p\<0.05.


Eligibility criteria:
inclusion criteria: * diagnosis of hypertension, controlled by up to three antihypertensive medications * blood pressure levels between 130 and 180 mmhg * no high cardiovascular risk (no other cardiovascular, metabolic or pulmonary disease nor any signals or symptoms of these disease) * not engaged in a physical exercise program for at least six months * not present cognitive impairment (montreal cognitive assessment ≥ 26 points) exclusion criteria: * adherence to less than 85% of training sessions * diagnosis of other cardiovascular diseases or diabetes during the course of the study * adherence to another supervised physical exercise program * change in medication class and/ or dose during the study * aggravation of the disease (i.e. blood pressure above 180 or use of four or more medications).
exercise therapy on rheological functions of erythrocyte in hemodialysis

Conditions: Hemodialysis Complication

Summary: to improve aerobic capacity, muscular function, and health-related quality of life in patients with end-stage renal disease (esrd), regular exercise is recommended. supervised intradialytic exercise at moderate intensity is a viable approach to ensure patient safety, maintain compliance, and effectively enhance physiological adaptations. however, the impact of exercise training on erythrocyte rheological properties in esrd patients, such as red blood cell deformability, aggregation, and oxygen transport capacity, remains unclear. method: esrd patients (anticipated n=180) will undergo supervised exercise training therapy three times per week for six months in the hospital, followed by three months at home. cardiopulmonary exercise tests will be conducted before and after the intervention. erythrocyte deformability and aggregation will be assessed using a laser-assisted optical rotational cell analyzer (lorca), while additional protein levels and reactive oxygen species (ros) status will be measured using a flow cytometer. this will help determine how exercise affects the rheological properties of red blood cells in this population.

renal dysfunction often stems from cardiovascular-related comorbidities or metabolic disorders, leading to the accumulation of excessive inflammatory products or damaging the bioenergetic health of red blood cells. this eventually contributes to the development of chronic kidney disease (ckd). at the most advanced stage, known as end-stage renal disease (esrd), patients suffer from severe uremia and renal failure, necessitating renal replacement therapy, typically in the form of dialysis. hemodialysis (hd) is the most common treatment for esrd patients, especially in taiwan, which has the highest global prevalence of hd due to related chronic diseases and a comprehensive national health insurance program. however, long-term maintenance hd is associated with physical inactivity and a low quality of life. as a result, exercise training is recommended to improve physiological adaptations and enhance functional capacity in hd patients. supervised intradialytic exercise in clinical settings offers a safer and more progressive approach, leading to low dropout rates and better compliance. red blood cell dysfunction is a significant issue in esrd, as impaired red blood cells can affect their deformability, aggregation, and oxygen transport capacity. the purpose of this study is to establish reliable measurements of red blood cell function in hd patients and assess cardiovascular and muscular fitness, along with the effects of intradialytic exercise on these parameters.

Eligibility criteria:
inclusion criteria: * receiving hemodialysis and medication at least for 6 weeks * kt/v score \> 1.2 exclusion criteria: * under 20 years-old * hyperkalemia occurs within 3 month * having orthopedic or muscular diseases * other concerned medical, psychological or physiological diseases * pregnancy * other exercise contraindications

Keywords: hemodialysis exercise training erythrocyte rheology